Back to results

Dual Target CAR-T Cells in B-cell Lymphoma (CAR-T)

Primary Purpose

Lymphoma, B-Cell, Relapse/Recurrence, Refractory Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

dual target CAR-T cell therapy

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must meet the following criteria to participate in this study:
1. 14-75 years old, no gender limit;
2. Diagnosed as relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
3. ECOG behavior status score is 0-2 points;
4. Expected survival time ≥ 3 months;
5. No contraindications to peripheral apheresis;
6. Flow cytometry/immunohistochemistry confirms that tumor cells express CD20;
7. Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
8. No serious heart, lung, liver or kidney disease;
9. Ability to understand and willing to sign the informed consent form for this trial.

Exclusion Criteria:

Patients with any of the following cannot be included in this study:
1. Tumor cells do not express CD20;
2. There is active infection;
3. Abnormal liver function (total bilirubin>1.5×ULN, glutamic-pyruvic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
4. People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
5. HIV/AIDS patients;
6. Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment;
7. Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
8. Known or suspected drug abuse or alcohol dependence;
9. People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
10. Those who have participated in other clinical trials within 30 days;
11. Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
12. The investigator judged that it is not suitable to participate in this trial.

Sites / Locations

Shenzhen University General hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Dual target CAR-T cell therapy

Outcomes

Primary Outcome Measures

Complete remission rate

All visible lesions disappeared completely and maintained at least 4 weeks.

Secondary Outcome Measures

Overall survival rate

The proportion of surviving patients at the end of the study.

Full Information

NCT ID

NCT04723914

First Posted

January 21, 2021

Last Updated

January 23, 2021

Sponsor

YuLi

1. Study Identification

Unique Protocol Identification Number

NCT04723914

Brief Title

Dual Target CAR-T Cells in B-cell Lymphoma

Acronym

CAR-T

Official Title

Clinical Trial of CD19/CD20 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 20, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

YuLi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma .

Detailed Description

Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma . Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD20 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, B-Cell, Relapse/Recurrence, Refractory Lymphoma, Dual-target CAR-T Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

Dual target CAR-T cell therapy

Intervention Type

Biological

Intervention Name(s)

dual target CAR-T cell therapy

Intervention Description

CD19/CD20 dual target CAR-T cell therapy

Primary Outcome Measure Information:

Title

Complete remission rate

Description

All visible lesions disappeared completely and maintained at least 4 weeks.

Time Frame

From date of initial treatment to the end of follow up, up to 2 years

Secondary Outcome Measure Information:

Title

Overall survival rate

Description

The proportion of surviving patients at the end of the study.

Time Frame

From admission to the end of follow up, up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must meet the following criteria to participate in this study: 14-75 years old, no gender limit; Diagnosed as relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria; ECOG behavior status score is 0-2 points; Expected survival time ≥ 3 months; No contraindications to peripheral apheresis; Flow cytometry/immunohistochemistry confirms that tumor cells express CD20; Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression; No serious heart, lung, liver or kidney disease; Ability to understand and willing to sign the informed consent form for this trial. Exclusion Criteria: Patients with any of the following cannot be included in this study: Tumor cells do not express CD20; There is active infection; Abnormal liver function (total bilirubin>1.5×ULN, glutamic-pyruvic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN); People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction; HIV/AIDS patients; Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment; Those who received radiotherapy within 4 weeks before the start of the study (blood sampling); Known or suspected drug abuse or alcohol dependence; People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures; Those who have participated in other clinical trials within 30 days; Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom); The investigator judged that it is not suitable to participate in this trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

shujiao he, Dr

Phone

+86-0755-21839178

he_shujiao@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Yu, Dr

Organizational Affiliation

Shenzhen University General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shenzhen University General hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518055

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shujiao He, Dr

Phone

+86-0755-2183-9178

he_shujiao@126.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan

Learn more about this trial

Dual Target CAR-T Cells in B-cell Lymphoma

We'll reach out to this number within 24 hrs